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Tecentriq assumes pole position with FDA approval but Keytruda looms in triple negative breast cancer, says GlobalData

On March 8, the FDA granted the accelerated approval of Roche’s programmed cell death protein 1 (PD-1) inhibitor Tecentriq in combination with Abraxane (protein-bound paclitaxel) for the treatment of locally advanced or metastatic triple-negative breast cancer (TNBC).

Adam Pearson, PhD, Oncology and Hematology Analyst at GlobalData, a leading data and analytics company, offers his view on the FDA approval of Tecentriq for TNBC:

“The emergence of Tecentriq as the first-in-class PD-1 inhibitor in breast cancer marks the first approval of an immuno-oncology drug in breast cancer and signifies the introduction of a new treatment strategy in a therapeutically elusive subset of breast cancer. It represents a win for Roche in a PD-1 inhibitor market dominated by Merck & Co.’s Keytruda and Bristol-Myers Squibb’s (BMS) Opdivo. Tecentriq is poised to temporarily monopolize the TNBC market until Merck & Co. is expected to release its Keytruda data from two Phase III trials this year.

“Therefore, despite the first-in-class success for Tecentriq in TNBC, Merck & Co.’s active testing of Keytruda in a single-agent setting and in combination with chemotherapy of physician’s choice, may ultimately allow Keytruda to be used in broader patient populations.

“Further opportunities exist in the neoadjuvant/adjuvant setting, in hormone-receptor-positive, and HER-2-positive breast cancers and finally, through novel combinations of PD-1 inhibitors with the approved poly ADP ribose polymerase (PARP) inhibitors in breast cancer patients harboring BRCA1 (breast cancer type 1 susceptibility protein) mutations. Each is an active area of investigation.

“Needless to say, competition will be fierce and each of the immuno-oncology players will strive to carve out a therapeutic niche within the breast cancer market.”